Phase 1 BA Study, Single Center With Healthy Volunteers

Single dose in healthy volunteers to assess bioavailability (amount of study drug in the system) between different formulations of ABT-874.

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator # 16001

Evansville, Indiana, 47710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must be healthy

Exclusion criteria

Subjects who are not healthy, enrolled in another study, or who have received ABT-874 previously.

Treatment and study plan

ABT-874

Drug

See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.

Primary outcomes

Bioavailability following single dose

Time frame: Hours: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 1008, 1344 for Regimens A, C, D and additional hours 4 & 8 for Regimen B and hours 0.5 and 6 hours for Regimen E

Secondary outcomes

AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study

Time frame: Through Day 85 (and / or 45 days after study drug stoppped)

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
First posted: Mar 27, 2009
Registry last updated: Nov 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed